Vardenafil Hydrochloride

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Vardenafil hydrochloride tablets are taken as needed:
• For most patients, the starting dose is 10 mg, up to once daily.
• Increase to 20 mg or decrease to 5 mg based on efficacy/tolerability.
• ( 2.1 ) A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥ 65 years of age.
• ( 2.3 ) Vardenafil hydrochloride tablets are taken orally, approximately 60 minutes before sexual activity.
• ( 2.1 ) The maximum recommended dosing frequency is one tablet per day.
• ( 2.1 ) Vardenafil hydrochloride tablets may be taken with or without food.
• ( 2.2 ) If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows ( 2.4 , 5.2 , 7.2 ):
• Ritonavir:
• No more than 2.5 mg in a 72-hour period Cobicistat:
• No more than 2.5 mg in a 72-hour period Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin:
• No more than 2.5 mg in a 24-hour period Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin:
• No more than 5 mg in a 24-hour period.
• In patients on stable alpha-blocker therapy the recommended starting dose of vardenafil hydrochloride tablets is 5 mg ( 2.4 , 5.6 ) The recommended starting dose of vardenafil hydrochloride tablets is 5 mg in patients with moderate hepatic impairment (Child-Pugh B).
• The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.
• ( 2.3 , 8.6 )
• 2.1 General Dose Information For most patients, the recommended starting dose of vardenafil hydrochloride tablets is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity.
• The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects.
• The maximum recommended dosing frequency is once per day.
• Sexual stimulation is required for a response to treatment.
• 2.2 Use with Food Vardenafil hydrochloride tablets can be taken with or without food.
• 2.3 Use in Specific Populations Geriatrics:
• A starting dose of 5 mg vardenafil hydrochloride tablets should be considered in patients ≥65 years of age [see Use in Specific Populations (8.5) ].
• Hepatic Impairment:
• For patients with moderate hepatic impairment (Child-Pugh B), a starting dose of 5 mg vardenafil hydrochloride tablets is recommended.
• The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg.
• Do not use vardenafil hydrochloride tablets in patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions (5.8) , Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .
• Renal Impairment:
• Do not use vardenafil hydrochloride tablets in patients on renal dialysis [see Warnings and Precautions (5.9 ), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].
• 2.4 Concomitant Medications Nitrates:
• Concomitant use with nitrates and nitric oxide donors in any form is contraindicated [see Contraindications (4.1) ] Guanylate Cyclase (GC) Stimulators, such as riociguat :
• Concomitant use is contraindicated [see Contraindications (4.2) ].
• CYP3A4 Inhibitors:
• The dosage of vardenafil hydrochloride tablets may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, cobicistat, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin [see Drug Interactions (7.2 ) ].
• If taking strong or moderate inhibitors of CYP3A4, the dose of vardenafil hydrochloride tablets should be adjusted as follows:
• Ritonavir:
• No more than 2.5 mg in a 72-hour period.
• Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin:
• No more than 2.5 mg in a 24-hour period.
• Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin:
• No more than 5 mg in a 24-hour period.
• Cobicistat: No more than 2.5 mg in a 72 hour period.
• Alpha-Blockers:
• In those patients who are stable on alpha-blocker therapy, phosphodiesterase type 5 (PDE5) inhibitors should be initiated at the lowest recommended starting dose.
• Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy.
• Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking a phosphodiesterase (PDE5) inhibitor including vardenafil.
• In those patients who are stable on alpha-blocker therapy, vardenafil hydrochloride tablets should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors). [See Warnings and Precautions (5.6) and Drug Interactions (7.1) .] A time interval between dosing should be considered when vardenafil hydrochloride tablets are prescribed concomitantly with alpha-blocker therapy [see Clinical Pharmacology (12.2) ] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

Side effects

• The following serious adverse reactions with the use of vardenafil hydrochloride tablets (vardenafil) are discussed elsewhere in the labeling:
• Cardiovascular Effects [see Contraindications (4.1) and Warnings and Precautions (5.1) ] Priapism [see Warnings and Precautions (5.3) ] Effects on Eye [see Warnings and Precautions (5.4) ] Sudden Hearing Loss [see Warnings and Precautions (5.5) ] QT Prolongation [see Warnings and Precautions (5.7) ] Most common adverse reactions reported ( ≥ 2% of patients) are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
• 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Vardenafil hydrochloride tablets were administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide.
• Over 2200 patients were treated for 6 months or longer and 880 patients were treated for at least 1 year.
• In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for vardenafil hydrochloride tablets compared to 1.1% for placebo.
• When vardenafil hydrochloride tablets were taken as recommended in placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1 ).
• Table 1:
• Adverse Reactions Reported By ≥2% of Patients Treated with Vardenafil Hydrochloride Tablets and More Frequent on Drug than Placebo in Fixed and Flexible Flexible dose studies started all patients at vardenafil hydrochloride tablets 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy.
• Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil Adverse Reaction Percentage of Patients Reporting Reactions Placebo N = 1199 Vardenafil Hydrochloride Tablets N = 2203 Headache 4% 15% Flushing 1% 11% Rhinitis 3% 9% Dyspepsia 1% 4% Accidental Injury All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury. 2% 3% Sinusitis 1% 3% Flu Syndrome 2% 3% Dizziness 1% 2% Increased Creatine Kinase 1% 2% Nausea 1% 2% Back pain was reported in 2.0% of patients treated with vardenafil hydrochloride tablets and 1.7% of patients on placebo.
• Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of vardenafil hydrochloride tablets.
• All Vardenafil Studies:
• Vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide.
• The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.
• In the placebo-controlled clinical trials for vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.
• The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of vardenafil hydrochloride tablets and vardenafil orally disintegrating tablets.
• Excluded from this list are those adverse reactions that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug:
• Body as a whole:
• allergic edema and angioedema, feeling unwell, allergic reactions, chest pain Auditory:
• tinnitus, vertigo Cardiovascular:
• palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive:
• nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal:
• increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia Nervous:
• paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Respiratory:
• dyspnea, sinus congestion Skin and appendages:
• erythema, rash Ophthalmologic:
• visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis Urogenital:
• increase in erection, priapism
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of vardenafil hydrochloride tablets.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
• Ophthalmologic:
• Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil.
• Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to:
• low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking [see Warnings and Precautions (5.4) and Patient Counseling Information (17) ] .
• Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience.
• It is not possible to determine whether these events are related directly to the use of vardenafil.
• Neurologic:
• Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.
• Otologic:
• Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil.
• In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.
• In many cases, medical follow-up information was limited.
• It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17) ] .

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

28 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Vardenafil Hydrochloride